Electromagnetic (em) Medical Device Instrument Tracking Apparatus

The following generally relates to ultrasound imaging, and finds particular application to an electromagnetic (EM) medical device instrument (e.g., a biopsy needle, an ablation catheter, etc.) tracking apparatus.

Ultrasound imaging provides real-time imaging of information about the interior of a subject such as tissue, organs, etc. An example ultrasound imaging system generally includes an ultrasound imaging probe and a console. The ultrasound probe houses a transducer array, and the console includes or is in electrical communication with a display monitor and a user interface. The transducer array transmits a pressure wave and receives echoes produced in response to the pressure wave interacting with structure such as tissue, blood cells, etc. The echoes are converted to analog signals, which are amplified, digitized, and beamformed to produce scan lines of radio frequency (RF) data. The scan lines are processed (e.g., band-pass filtering, envelope detection, logarithmic compression, etc.), scan converted, and displayed as a 2-D (B-mode) ultrasound image.

Some ultrasound imaging probes are configured for procedures performed in a cavity of the body, e.g., through small incisions to guide advancement of an instrument carried at a proximal end of a medical device to target tissue of interest for a procedure. An example of such an ultrasound imaging probe includes a handle, an elongated shaft, and a transducer array disposed at a proximal end of the shaft. An example of such a medical device includes a handle, an elongated shaft, and an instrument (e.g., a blade, a needle, scissors, an ablation catheter, etc.) for the procedure disposed at a proximal end of the shaft. An example of such a procedure includes an image-guided laparoscopic procedure such as an image-guided biopsy, ablation, etc. procedure.

In general, the elongated shaft of the ultrasound imaging probe is advanced through the incision and into the cavity and employed to localize the target tissue of interest. The elongated shaft of the medical device is also advanced through a different incision and guided to the target tissue of interest using ultrasound images. A tracking system tracks the spatial location of the ultrasound imaging probe and the medical device in three-dimensional (3-D) space, registers the coordinate systems of the ultrasound imaging system and the medical device, and superimposes graphical indicia representing the instrument over an ultrasound image generated with ultrasound data acquired with the ultrasound imaging probe and at an estimated location of the instrument with respect to the target tissue of interest in the ultrasound image.

In one instance, the tracking system includes an electromagnetic (EM) tracking system that detects signals from EM sensors employed with the ultrasound imaging probe and the medical device. In some instances, an external EM sensor is attached to a distal end of the elongated shaft of the medical device nearer to or in a region where the elongated shaft couples with the handle, and the signal from the EM sensor is utilized to estimate a spatial orientation of the instrument. Such placement of the EM sensor assumes a rigid elongated shaft where the spatial orientation of the instrument can be derived by adding the distance between the EM sensor and the instrument to the tracked location of the EM sensor at the coupling to the handle. However, the elongated shaft is not rigid and is susceptible to deflect. Unfortunately, deflection may result in an inaccurate estimation of the spatial orientation of the instrument. Even without deflection, angular errors accumulate over the distance between the EM sensor and the instrument, leading to an inaccurate estimation of the spatial orientation of the instrument.

In another instance, an EM sensor is physically integrated in and part of the elongated shaft of the medical device, e.g., near the tip of the medical device. Unfortunately, this ties the tracking to a specific technology provider, i.e., the technology provider of the medical device. In addition, the ultrasound imaging probe and the medical device usually originate from two different technology providers, and the coordinate systems of the ultrasound imaging probe and the medical device need to be registered to map the instrument (and optionally the elongated shaft) to the ultrasound image generated by the ultrasound imaging system. This further ties the tracking to the specific technology provider, i.e., an EM tracking platform of the technology provider. Furthermore, the particular medical device may not be the best or desired medical device for the procedure.

In view of at least the foregoing, there is an unresolved need for an improved approach for EM-based tracking of an instrument of a medical device for an ultrasound image-guided procedure and/or other procedure.

Aspects of the application address the above matters, and others. This summary introduces concepts that are described in more detail in the detailed description. It should not be used to identify essential features of the claimed subject matter, nor to limit the scope of the claimed subject matter.

In one aspect, an electromagnetic medical device instrument tracking apparatus includes an elongated hollow channel. The elongated hollow channel includes a cylindrically shaped body configured to receive elongated shafts of medical devices having instruments at ends of the elongated shafts, a distal end, an inlet at the distal end, a proximal end, and an outlet at proximal end. The elongated hollow channel further includes a fastener coupled at the distal end. The elongated hollow channel further includes at least one electromagnetic sensor disposed at the proximal end. The elongated hollow channel further includes an electrical pathway in electrical communication with the at least one electromagnetic sensor and configured to route signals from the at least one electromagnetic sensor off the apparatus The cylindrically shaped body positions the electromagnetic sensor by an instrument located at an end of an elongated shaft of a medical device installed in the cylindrically shaped body.

In another aspect, a method includes selecting a medical device for a procedure, wherein the medical device includes an elongated shaft carrying an instrument at a proximal end. The method further includes selecting an EM medical device instrument tracking apparatus corresponding to the selected medical device. The EM medical device instrument tracking apparatus includes an elongated hollow channel. The elongated hollow channel includes a cylindrically shaped body configured to receive elongated shafts of medical devices having instruments at ends of the elongated shafts, a distal end, an inlet at the distal end, a proximal end; and an outlet at proximal end. The elongated hollow channel further includes a fastener coupled at the distal end. The elongated hollow channel further includes at least one electromagnetic sensor disposed at the proximal end. The elongated hollow channel further includes an electrical pathway in electrical communication with the at least one electromagnetic sensor and configured to route signals from the at least one electromagnetic sensor off the apparatus. The method further includes installing the selected medical device in the EM medical device instrument tracking apparatus. The cylindrically shaped body positions the electromagnetic sensor by an instrument located at an end of an elongated shaft of a medical device installed in the cylindrically shaped body. The method further includes fastening the selected medical device and the EM medical device instrument tracking apparatus together. The method further includes connecting the electrical pathway of the EM medical device instrument tracking apparatus to the tracking system.

In another aspect, an electromagnetic medical device instrument tracking apparatus includes an elongated hollow channel. The elongated hollow channel includes a proximal end. The electromagnetic medical device instrument tracking apparatus further includes at least one electromagnetic sensor disposed at the proximal end of the elongated hollow channel. The electromagnetic medical device instrument tracking apparatus further includes an electrical pathway in electrical communication with the at least one electromagnetic sensor.

Those skilled in the art will recognize still other aspects of the present application upon reading and understanding the attached description.

Embodiments of the present disclosure will now be described, by way of example, with reference to the figures, in which a system and/or a method includes an electromagnetic (EM) medical device instrument tracking apparatus. In one instance the EM medical device instrument tracking apparatus at least includes an elongated hollow channel configured to receive an elongated shaft of a medical device carrying an instrument (e.g., a biopsy needle, an ablation catheter, etc.) of the medical device, at least one EM sensor disposed nearer a proximate end of the elongated hollow channel (relative to the opposing distal end of the elongated hollow channel), an electrical pathway configured to route signals from the EM sensor off the EM medical device instrument tracking apparatus, and a fastening mechanism for fastening the EM medical device instrument tracking apparatus to the medical device.

As previously discussed, with existing approaches, an external EM sensor is attached to a distal end of the elongated shaft of the medical device nearer to or in a region where the elongated shaft couples with the handle and away from the instrument, and the signal from the EM sensor is utilized to estimate a spatial orientation of the instrument, which may result in an inaccurate estimation of the spatial orientation of the instrument, e.g., due to an accumulation of angular errors and/or deflection of the elongated shaft, and, hence, the instrument. Alternatively, the EM sensor is physically integrated in the elongated shaft, near the tip of the medical device, which, unfortunately, ties tracking to a specific technology provider, i.e., the technology provider of the medical device and the EM tracking platform of the technology provider, and the medical device may not be the best or desired medical device for the procedure.

The approach described herein mitigates such shortcomings of the aforementioned existing approaches and/or other shortcomings. As described in greater detail below, the EM medical device instrument tracking apparatus is separate from the medical device and includes at least one EM sensor. The medical device is installed in and/or received by the EM medical device instrument tracking apparatus, which positions the at least one EM sensor near the proximate end of the elongated hollow channel, and hence, the instrument carried by the elongated shaft of the medical device. With this approach, tracking is not tied to any particular medical device and/or technology provider of the medical device and is not subject to inaccurate estimates due to angular errors and the distance between the EM sensor and the instrument and/or deflection of the elongated shaft of the medical device carrying the instrument.

1 FIG. 100 102 104 106 110 112 100 116 118 119 schematically illustrates a systemthat includes an EM medical device instrument tracking apparatusin connection with a medical deviceconfigured for at least an ablation procedure (e.g., includes an ablation catheter, etc.), a biopsy procedure (e.g., includes a blade, a needle, scissors, etc.), an ultrasound imaging system, a tracking system, and an image guidance system. For explanatory purposes, the systemis illustrated in connection with a subjectwith a cavitythat includes a target of interestfor the procedure. Medical devices with other instruments for similar and/or other procedures are also contemplated herein.

2 3 FIGS.and 1 FIG. 2 FIG. 3 FIG. 1 3 FIGS.- 102 102 102 102 200 204 206 208 204 204 102 schematically illustrate an example of the EM medical device instrument tracking apparatuswithout the other components and/or systems illustrated in.schematically illustrates a side view of the EM medical device instrument tracking apparatus, andschematically illustrates a perspective view of the EM medical device instrument tracking apparatus. With reference to, the EM medical device instrument tracking apparatusincludes an elongated hollow channel (e.g., a sheath, a canula, etc.), at least one EM sensor, a fastener, and an electrical pathwayfor the at least one EM sensorfor routing signals from the at least one EM sensoroff of the EM medical device instrument tracking apparatus.

200 210 212 214 216 210 218 212 202 202 220 222 220 222 104 202 104 222 202 In this example, the elongated hollow channelincludes a cylindrically shaped body with a distal end, a proximal end, a hollow tubular cavity, an inletat the distal end, and an outletat the proximal end. In another instance, the elongated channelincludes an elliptical, oval, and/or otherwise shaped body. The cylindrically shaped bodyhas a lengthand a diameter. In general, the lengthand the diameterare configured based on a gauge (i.e., a diameter) of a shaft of the medical deviceas the cylindrically shaped bodyis configured to receive the shaft of the medical device. That is, the diameteris large enough to receive the shaft (and possibly one or more other items), while minimizing space between the cylindrically shaped bodyand the shaft.

102 204 204 224 202 204 204 224 204 226 202 204 202 204 226 The illustrated EM medical device instrument tracking apparatusfurther includes an EM sensor. The EM sensoris disposed at a proximal end regionof the cylindrically shaped body. In another instance, the EM sensoris disposed with a gap between the EM sensorand the proximal end region. Further, the illustrated EM sensoris disposed on an outer surfaceof the cylindrically shaped body. In another instance (and as described below), the EM sensoris otherwise disposed in connection with the cylindrically shaped body. Any known technique and/or other approaches for securing the EM sensorto the outer surfaceis contemplated herein.

204 204 204 204 202 202 202 In one instance, the EM sensorincludes a passive EM sensor. In another instance, the EM sensorincludes an active EM sensor. In yet another instance, the EM sensorincludes a combination of a passive EM sensor and an active EM sensor. In any instance, the EM sensorincludes a coil, an element, and/or other EM sensor technology. In another instance, an inertial tracking device is alternatively or additionally utilized. A suitable EM sensor for determining a spatial orientation of cylindrically shaped bodyincludes at least five (5) degrees of freedom. For example, a five (5) degrees of freedom EM sensor would allow for determining a spatial orientation of cylindrically shaped bodyabout itself. In another instance, the EM sensor includes six (6) degrees of freedom, which allows for determining a spatial orientation of cylindrically shaped bodyin three-dimensional (3-D) space.

206 210 102 206 102 104 206 104 206 The fastening memberis coupled at the distal endof EM medical device instrument tracking apparatus. The fastening memberis configured to fasten the EM medical device instrument tracking apparatusto the medical device. In one instance, the fastening memberincludes one of two complementary sides configured to engage, where the medical deviceinclude the other complementary side (as discussed below). For example, one of the two sides may include external threads and the other of the two sides may include complementary internal threads. Other mechanisms such as a clamp, a screw, etc. are contemplated herein. The illustrated shape of the fastening memberis for explanatory purposes and is not limiting.

208 204 226 202 208 204 102 208 226 210 226 206 208 206 208 226 The electrical pathway, similar to the EM sensor, is disposed on the outer surfaceof the cylindrically shaped body. The electrical pathwayis in electrical communication with the EM sensorand routes signals therefrom off the EM medical device instrument tracking apparatus. In the illustrated example, the electrical pathwayruns along the outer surfaceto about the distal endand then extends off of the outer surfaceand around the fastening member. In another instance, the electrical pathwayis routed through the fastening member. Any known technique and/or other approaches for securing the electrical pathwayto the outer surfaceis contemplated herein.

1 FIG. 104 120 120 108 122 124 120 126 128 124 206 102 102 104 With reference to, the medical deviceincludes an elongated shafthaving a long axis. The elongated shaftcarries the instrumentat a proximal end. An opposing distal endof the elongated shaftis coupled to a handle. A fastening memberdisposed at the opposing distal endacts in conjunction with the fastening memberof the EM medical device instrument tracking apparatus, e.g., as a second side of complementary sides, etc., for securing or fastening the EM medical device instrument tracking apparatusto the medical device.

4 4 FIGS.A andB 1 4 FIGS.andA 1 4 FIGS.andB 104 108 402 108 108 404 404 406 406 108 schematically illustrate example prior art medical devices. With reference to, the instrumentincludes a bladefor a biopsy procedure. In another instance, the instrumentcarries a needle, scissors, etc. With reference to, the instrumentincludes an ablation catheter. The illustrated ablation catheterhas an active regionthat is around one to two centimeters in length. Other size active regionsare also contemplated herein. In other instances, the instrumentincludes a radiofrequency (RF) catheter, a microwave catheter, cryoablation catheter, a laser, and/or other instrument.

1 FIG. 1 FIG. 5 FIG. 1 5 FIG.- 102 104 104 102 220 202 204 202 502 204 108 108 502 With reference to, as described herein, the EM medical device instrument tracking apparatusis configured to receive the elongated shaft of the medical device. A magnified view of a portion the medical deviceand the EM medical device instrument tracking apparatusfromis schematically illustrated in. With reference to, in general, the lengthof the cylindrically shaped bodyand the location of the EM sensoron the cylindrically shaped bodyare such that a distancebetween the EM sensorand the instrumentis as short as reasonably possible to the instrument. In one instance, the distanceis on an order of one centimeter or less.

108 204 108 The actual distance depends on the instrumentand/or other factors. In general, the closer the EM sensoris to the instrument, the more accurate the tracking will be.

As previously discussed, with existing approaches, an external EM sensor is attached to a distal end of the elongated shaft of the medical device near to or in a region where the elongated shaft couples with the handle, and the signal from the EM sensor is utilized to estimate a spatial orientation of the instrument, where such placement of the EM sensor assumes a rigid elongated shaft and the spatial orientation of the instrument is derived by adding the distance between the EM sensor and the instrument to the tracked location of the EM sensor at the coupling to the handle, and this may result in an inaccurate estimation of the spatial orientation of the instrument, e.g., due to an accumulation of angular errors and/or deflection of the elongated shaft, and, hence, the instrument.

Alternatively, the EM sensor is physically integrated in the elongated shaft, near the tip of the medical device, which ties tracking to a specific technology provider, i.e., the technology provider of the medical device. In addition, the ultrasound imaging probe and the medical device usually originate from two different technology providers, and the ultrasound imaging probe and the medical device need to be registered to a same coordinate system to map the elongated shaft of the medical device to the image generated by the ultrasound imaging system, which further ties tracking to the specific technology provider, i.e., EM tracking platform of the technology provider. In addition, the medical device may not be the best or desired medical device for the procedure.

102 104 204 104 102 204 212 202 108 120 104 The approach described herein mitigates such shortcomings and/or other shortcomings of the aforementioned existing approaches. As described in greater detail below, the EM medical device instrument tracking apparatusis separate from the medical deviceand includes at least one EM sensor. The medical deviceis installed in and/or received by the EM medical device instrument tracking apparatus, which places the at least one EM sensornear the proximate endof the cylindrically shaped body, and, hence, the instrumentcarried by the elongated shaftof the medical device. With this approach, tracking is not tied to any particular medical device and/or technology provider of the medical device and is not subject to inaccurate estimates due to angular errors and the distance between the EM sensor and the instrument and/or deflection of the elongated shaft of the medical device carrying the instrument.

1 FIG. 102 104 130 116 130 132 134 136 130 102 104 120 118 116 Returning to, the EM medical device instrument tracking apparatusand the medical deviceare shown in connection with a trocarin an incision in an outer wall of the subject. The illustrated trocarincludes a rigid hollow elongated tube, a port, and a tapered tip. The trocarserves as a minimally invasive gateway for the EM medical device instrument tracking apparatus, and, thus, the medical deviceto the target of interestin the cavityof the subject.

106 140 142 140 142 The ultrasound imaging systemincludes an ultrasound imaging probeand a console. The ultrasound imaging probeand the consoleinterface with each other via a communication channel, which includes wired technology, e.g., complimentary interfaces and a cable therebetween (as illustrated), and/or wireless technology, e.g., Wi-Fi, etc.

140 144 146 146 146 146 The ultrasound imaging probeincludes an elongated shaftwith opposing ends. A transducer arrayis disposed at one of the ends. The transducer arrayincludes one or more transducer elements. Examples of suitable arrays include 64, 128, 192, 256, and/or other arrays, including larger and smaller arrays, one dimensional (1-D) or two dimensional (2-D), etc. The transducer arraycan be linear, curved, and/or otherwise shaped, fully populated, sparse and/or a combination thereof, etc. The transducer arrayis configured to convert an excitation electrical signal to an ultrasound pressure field and vice versa.

By way of non-limiting example, the one or more transducer elements can be selectively excited via an excitation electrical (pulsed) signal, which causes at least a sub-set of the transducer elements to transmit an ultrasound pressure field into an examination or scan field of view. The ultrasound pressure field may include a focused ultrasound beam, a defocused (spherical) wave, and/or other ultrasound signal. The one or more transducer elements receive echo signals and generate analog electrical signals indicative thereof. The echo signals are generated in response to the transmitted ultrasound pressure field interacting with structure, such as tissue and/or blood cells flowing in a portion of a vessel.

140 148 148 144 146 148 140 148 140 148 148 140 150 158 The ultrasound imaging probefurther includes a tracking sensor. The tracking sensoris located at a same end of the elongated shaftas the transducer array. In this example, the tracking sensoris integrated with the ultrasound imaging probe. In another instance, the tracking sensoris removably attached to the ultrasound imaging probe. An example of the tracking sensorinclude an EM tracking sensor, an inertial tracking device, etc. In another instance, the tracking sensoris disposed elsewhere in the ultrasound imaging probe. A handleis disposed at the other end of the shaft.

140 152 130 152 154 156 158 152 144 140 146 148 140 108 120 118 116 The ultrasound imaging probeis shown in connection with a trocar, which is substantially similar to the trocar. The illustrated trocarincludes a rigid hollow elongated tube, a port, and a tapered tip. The trocarserves as a minimally invasive gateway for the elongated shaftof the ultrasound imaging probe, and, thus, the transducer arrayand tracking sensor. The ultrasound imaging probeis used to guide the instrumentto the target of interestin the cavityof the subject.

142 160 146 146 The consoleincludes a transmit circuitconfigured to generate the excitation electrical signal provided to transducer arrayfor transmitting the ultrasound pressure field. In one instance, this includes generating delays for individual elements of the transducer array, e.g., for transmit focusing, beam steering, etc.

142 162 162 162 The consolefurther includes a receive circuitconfigured to receive the analog electrical signals. In one instance, the receive circuitis further configured to pre-process the analog electrical signals, e.g., amplify, digitize, focus, and/or otherwise process the analog electrical signals. For example, in one instance the receive circuitincludes an amplifier and a corresponding analog to digital converter (ADC) for each element, where each amplifier amplifies a corresponding analog electrical signal from a micro-volt level to a voltage range of the ADC.

142 163 160 162 160 146 162 146 160 162 The consolefurther includes a switchconfigured to switch between the transmit circuitand the receive circuit, e.g., by electrically connecting the transmit circuitto the transducer arrayfor a transmit operation and electrically connecting the receive circuitto the transducer arrayfor a receive operation. In an alternative instance, separate switches are employed for each of the transmit circuitand the receive circuit.

142 164 164 162 164 The consolefurther includes a beamformer. For receive operations, the beamformeris configured to beamform, e.g., via delay-and-sum (e.g., a matched-filter beamformer, etc.) and/or other beamforming, the signals from the receive circuitand construct a scanplane of scanlines of radiofrequency (RF) data (RF signal) for the echoes for each receive operation. With delay-and-sum beamforming, the digital signal for each element is delayed to align the signals in time, amplified, and then summed. The output of the beamformerincludes the RF signal.

142 166 166 The consolefurther includes a scanline processorconfigured to perform other processing on the data such as filtering (e.g., via a Finite Impulse Response (FIR) filter, an Infinite Impulse Response (IIR) filter, etc.), Time Gain Compensation (TGC), I/Q demodulation, envelope detection, logarithmic compression, noise rejection, and/or other processing, and output frames of data. When configured for I/Q demodulation, the scanline processordown mixes the RF signal and, optionally, apply low pass filtering and/or decimation. This may include employing a Hilbert Transform, a combination of a Complex-Demodulation Band Pass Filter and optional decimation, and/or other processing.

166 166 166 166 166 The scanline processordetects and extracts the envelope (e.g., an amplitude) of the I/Q signal (when the scanline processorI/Q demodulates the RF signal) or the RF signal (when the scanline processordoes not I/Q demodulate the RF signal). In one instance, this is achieved using a Hilbert Transform and/or other approach. The scanline processorcompresses the extracted envelope, reducing the dynamic range thereof, e.g., to reduce the dynamic range to a predetermined display precision by a logarithmic (log)-based dynamic range compression and/or otherwise, and outputs a scanline. The scanline processoroutputs the processed scanlines as a frame/image (e.g., a B-mode image).

142 168 168 170 168 170 142 170 142 The consolefurther includes a scan converter. The scan converteris configured to scan convert the image into a coordinate system of an ultrasound system (US) display. The scan convertercan be configured to employ analog and/or digital scan converting techniques. The ultrasound system displayis integrated with the console. In another instance, ultrasound system displayis a separate and/or remote display monitor in electrical communication with the console.

142 172 172 172 106 172 104 172 142 172 142 The consolefurther includes a user interface (U/I). The user interfaceincludes one or more input devices (such as a button, a knob, a slider, a touch screen, a mouse, a keyboard, etc.) and/or other input device, and/or one or more output devices such as a visible, audible, etc. indicator. The user interfaceallows a user to control an operation of the ultrasound imaging system. For example, in one instance, user interfacereceives an input indicative of an imaging protocol including tracking of the medical device. The user interfaceis shown integrated with the console. In another instance, the user interfaceis a separate and/or remote keyboard, keypad, touch screen, etc. in electrical communication with the console.

142 174 174 174 160 162 163 164 166 168 170 172 142 The consolefurther includes a controller. The controllerincludes a processor(s) such as a microprocessor (mP), a central processing unit (CPU), a graphics processing unit (GPU), etc., and computer readable storage medium. The computer readable storage medium includes computer readable instructions, and the processor is configured to execute instructions stored in the computer readable storage medium. The controlleris configured to control one or more of the transmit circuit, the receive circuit, the switch, the beamformer, the scanline processor, the scan converter, the ultrasound imaging display, and the user interface. One or more of the components of the consolecan be implemented in software and/or hardware.

110 110 104 110 204 208 204 110 110 204 108 204 104 The tracking systemcan be a passive EM tracking system or an active EM tracking system. In either instance, the tracking systemis configured to track a position and an orientation of the medical device. With a passive EM tracking system, the tracking systemgenerates a defined external electromagnetic field. The EM sensoris configured to generate signals in response to excitation by the external electromagnetic field. The signal is routed via the electrical pathwayalong the side of the cylindrical bodyto the tracking system. The tracking systemprocesses the signal to determine the position and orientation of the EM sensorin real-time. With an active EM tracking system, as the medical instrumentmoves in the electromagnetic field, the EM sensorgenerate signals, which are detected and processed to continuously track the position and orientation of the medical devicein real-time.

112 176 178 180 178 176 178 180 112 180 112 The image guidance systemincludes at least a processor(e.g., a central processing unit, a microprocessor, etc.), a memory(i.e., computer readable medium, which includes physical memory, etc., and excludes transitory medium such as a signal, carrier wave or other transitory medium), and an image guided system (IGS) display. The memoryincludes computer readable instructions, and the processoris configured to execute instructions stored in the memory. The image guided system displayis shown integrated with the image guidance system. In another instance, the image guided system displayis a separate and/or remote display monitor in electrical communication with the image guidance system.

178 182 110 166 106 108 182 108 108 108 120 108 The memoryincludes a tracking moduleconfigured to process the location and/or direction information from the tracking systemand image from the scanline processorof the ultrasound imaging system. In one instance, where the instrumentis in a plane of the ultrasound beam, the tracking moduledisplays the image with graphical indicia at an estimated location of at least the instrumentsuperimposed or overlaid over the image, providing real-time display of images and the estimated location of at least the instrument. An example of suitable indicia includes a crosshair at an estimated location of a tip of the instrument. Another example additionally includes an end portion of the elongated shaftalong with the instrument.

1 3 5 FIGS.-and 6 FIG. 204 208 226 202 102 204 208 202 204 208 602 202 202 104 204 208 204 602 In, the EM sensorand the electrical pathwayare disposed on the outer surfaceof the cylindrical shaped body.schematically illustrates another example of the EM medical device instrument tracking apparatusin which the EM sensorand the electrical pathwayare disposed inside of the cylindrically shaped body. In this example, the EM sensorand the electrical pathwayare on an inner surfaceof the cylindrical shaped body. In this example, the diameter of the cylindrical shaped bodyis configured to include enough space at least for the elongated shaft of the medical device, the EM sensor, and the electrical pathway. Any known technique and/or other approaches for securing the EM sensorto the inner surfaceis contemplated herein.

1 3 5 FIGS.-and 7 8 9 10 FIGS.,,and 7 FIG. 8 FIG. 9 FIG. 10 FIG. 7 8 9 FIGS.,and 102 204 132 102 204 204 202 204 202 204 202 In, the EM medical device instrument tracking apparatusinclude a single sensor, the EM sensornear the tip.schematically illustrate variations in which the EM medical device instrument tracking apparatusincludes at least two of the EM sensors.depicts an example with two or more of the EM sensorsarranged along a same side between ends of the cylindrical shaped body.depicts an example with two or more of the EM sensorsarranged along different sides at a same end of the cylindrical shaped body.depicts an example with two or more of the EM sensorsarranged along different sides and not at the same end of the cylindrical shaped body.depicts a combination of the examples described in connection with.

7 8 9 10 FIGS.,,and 208 208 204 208 204 204 208 204 102 208 In, the electrical pathwayis not shown for clarity and explanatory purposes. However, it is to be appreciated that in one instance a single electrical pathwaymay be utilized with multiple EM sensors, while in another instance, multiple electrical pathwaysmay be utilized with multiple EM sensors, including one to one, one to many, etc. combinations. For example, in one instance multiple EM sensorsare included on a single integrated chip (IC) and a single electrical pathwayroutes signals from the multiple EM sensorsoff the EM medical device instrument tracking apparatus. For example, the IC may include two EM sensors, each with five (5) degrees of freedom, and a single electrical pathway.

7 FIG. 102 204 702 204 702 226 202 202 204 702 202 206 204 702 102 204 702 108 Initially referring to, the EM medical device instrument tracking apparatusincludes the EM sensor, . . . , and an EM sensor. The EM sensor, . . . , and the EM sensorare both located on the outer surfaceof the cylindrical shaped body, along a straight line between the ends of the cylindrical shaped body. In this example, the EM sensoris located as close as reasonably possible to the end, as described herein. The EM sensoris located at the opposing end of the cylindrical shaped body, near the fastener. Other EM sensors would be located therebetween. In another instance, at least one of the EM sensorsand the EM sensoris located with a space therebetween and at the end. In one instance, the EM medical device instrument tracking apparatusincludes only two sensors, the EM sensorand the EM sensor, spaced apart. In general, employing two such EM sensors may improve an accuracy of the estimated spatial orientation of the instrument, relative to a single EM sensor.

8 FIG. 102 204 802 204 702 202 202 204 704 802 204 802 704 204 802 128 202 204 802 202 Moving to, the EM medical device instrument tracking apparatusincludes the EM sensor, . . . , and an EM sensor. The EM sensor, . . . , and the EM sensorare arranged around a perimeter at the cylindrical shaped body, on opposing sides of the cylindrical shaped body. The EM sensoris located on the side. The EM sensoris located opposite the EM sensor, on a sideopposite of the side. In this example, where there are other EM sensors, they would be located between the EM sensorand the EM sensoraround the perimeter at the endof the cylindrical shaped body. In a variation, at least one of the EM sensorsand/oris disposed with a space between the sensor and the end of the cylindrical shaped body.

9 FIG. 102 204 902 204 902 202 204 704 902 904 704 804 704 804 904 204 902 202 Moving to, the EM medical device instrument tracking apparatusincludes the EM sensor, . . . , and an EM sensor. The EM sensor, . . . , and the EM sensorare arranged on different sides and different ends of the cylindrical shaped body. The EM sensoris located on the side. The EM sensoris located on a side, which is between the sideand the side. In this example, where there are other EM sensors, they would be likewise located between the sideand the side, on and/or off of the side. In a variation, at least one of the EM sensorsand/oris disposed with a space between the EM sensor and the end of the cylindrical shaped body.

10 FIG. 7 8 9 FIGS.,and/or 10 FIG. 7 8 9 FIGS.,and 6 FIG. 102 204 702 802 902 204 702 802 902 226 124 202 depicts an example that is a combination of the examples described in connection with. For example, in, the EM medical device instrument tracking apparatusincludes the EM sensorand two or more of the EM sensors,and/or. Another variation includes one of the examples discussed in connection withor a combination thereof, but with at least one of the sensors (e.g., the EM sensor, the EM sensor, the EM sensor, the EM sensor, etc.) disposed on the inner surfaceof the cylindrical body, e.g., as discussed in connection with the example ofand/or otherwise.

11 12 13 FIGS.,and 11 FIG. 12 FIG. 13 FIG. 11 FIG. 12 FIG. 102 104 104 102 104 102 schematically illustrates a plurality of the EM medical device instrument tracking apparatusesin conjunction with a plurality of the medical devices.schematically illustrates a set of the medical devices.schematically illustrates a set of the EM medical device instrument tracking apparatuses.schematically illustrates the set of the medical devicesdescribed in connection withinstalled in the set of the EM medical device instrument tracking apparatusesdescribed in connection with.

11 FIG. 1100 104 1102 1102 1102 1 N Initially referring to, a setof the medical devicesincludes a medical device, . . . , and a medical device, (collectively referred to herein as medical devices), where N is an integer equal to or greater than one.

1102 1104 1106 1108 1104 1110 1112 1106 1110 1108 1112 1108 1 1 1 1 1 1 1 1 1 1 1 1 The medical deviceincludes an elongated shaft, a fastening member, and an instrument. The elongated shafthas a first endand an opposing second end. The fastening memberis coupled to the first end. The instrumentis coupled to the opposing second end. The instrumentcan include a biopsy needle, an ablation catheter, etc.

1102 1104 1106 1108 1104 1110 1112 1106 1110 1108 1112 1108 N N N N N N N N N N N N The medical deviceincludes an elongated shaft, a fastening member, and an instrument. The elongated shafthas a first endand an opposing second end. The fastening memberis coupled to the first end. The instrumentis coupled to the opposing second end. The instrumentcan include a biopsy needle, an ablation catheter, etc.

1102 1102 1104 1102 1104 1102 1102 1102 1104 1104 1102 1 N 1 1 N N 1 N 1 N The illustrated medical deviceand the illustrated medical deviceare substantially similar except that a diameter of the elongated shaftof medical deviceis smaller than a diameter of the elongated shaftof medical device. Medical devices between the medical deviceand the medical devicehave other diameters. For example, their diameters are between the diameters of the elongated shaftand the elongated shaft. In another instance, other attributes (e.g., length, instrument, etc.) of the medical devicesare different.

12 FIG. 1200 1202 1202 1202 1202 1204 1206 1208 1210 1212 1202 1204 1206 1208 1210 1212 1 N 1 1 1 1 1 1 N N N N N N Moving to, a set of the EM medical device instrument tracking apparatusesincludes an EM medical device instrument tracking apparatus, . . . , and an EM medical device instrument tracking apparatus, (collectively referred to herein as EM medical device instrument tracking apparatuses). The EM medical device instrument tracking apparatusincludes a cylindrical shaped bodywith a distal end, a proximal end, an EM sensor, and an electrical pathway. The EM medical device instrument tracking apparatusincludes a cylindrical shaped bodywith a distal end, a proximal end, an EM sensor, and an electrical pathway.

1202 1202 1204 1202 1204 1202 1202 1202 1204 1204 1202 1 N 1 1 N N 1 N 1 N The illustrated EM medical device instrument tracking apparatusand the illustrated medical device EM medical device instrument tracking apparatusare substantially similar except that a diameter of the cylindrical shaped bodyof the EM medical device instrument tracking apparatusis smaller than a diameter of the cylindrical shaped bodyof the EM medical device instrument tracking apparatus. EM medical device instrument tracking apparatuses between the EM medical device instrument tracking apparatusand the EM medical device instrument tracking apparatushave other diameters. For example, their diameters are between the diameters of the cylindrical shaped bodyand the cylindrical shaped body. In other instance, other attributes (e.g., length, etc.) of the apparatusesare different.

13 FIG. 1100 1200 1104 1102 1204 1202 1106 1102 1204 1202 1104 1102 1204 1202 1206 1102 1206 1202 1 1 1 1 1 1 N 1 N N N N N N N N Turning to, the set of the medical devicesare respectively installed in the set of the EM medical device instrument tracking apparatus. The shaftof the medical deviceis inside of the cylindrical shaped bodyof the EM medical device instrument tracking apparatus. The fastening memberof the medical deviceis engaged with the fastening memberof the EM medical device instrument tracking apparatus. The shaftof the medical deviceis inside of the cylindrical shaped bodyof the EM medical device instrument tracking apparatus. The fastening memberof the medical deviceis engaged with the fastening memberof the EM medical device instrument tracking apparatus.

11 12 13 FIGS.,and 1202 1202 1102 1102 1204 1204 1202 1202 1104 1104 1102 1102 1204 1204 1202 1202 1204 1204 1202 1202 1104 1104 1102 1102 1210 1210 1108 1108 1202 1202 1108 1108 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N 1 N In, each of the EM medical device instrument tracking apparatuses, . . . ,is configured based on a corresponding one of the medical devices, . . . ,in that a diameter of the cylindrical shaped bodies, . . . ,of the EM medical device instrument tracking apparatuses, . . . ,corresponds to a diameter of the shafts, . . . ,of the medical devices, . . . ,. For example, in one instance each of the cylindrical shaped bodies, . . . ,of the EM medical device instrument tracking apparatuses, . . . ,is configured to minimize or optimize a gap between the cylindrical shaped bodies, . . . ,of the EM medical device instrument tracking apparatuses, . . . ,and the shafts, . . . ,of the medical devices, . . . ,so that the EM sensors, . . . ,more accurately tracks the instruments, . . . ,relative to a larger gap where the sensors, . . . ,are further away from the instruments, . . . ,.

14 FIG. 11 13 FIGS.and 11 13 FIGS.and 102 104 1102 1102 1402 1404 1406 1408 1410 1412 1404 1104 1104 1102 1102 1402 1102 1102 1402 1102 1 N 1 N 1 N 1 N 1 schematically illustrates another example in which the EM medical device instrument tracking apparatusis configured to receive any of a set of different sized medical devicessuch as the medical devices, . . . ,described in connection with. A EM medical device instrument tracking apparatusincludes a cylindrical shaped bodywith a distal end, a proximal end, an EM sensor, and an electrical pathway. In this example, a diameter of the cylindrical shaped bodyis larger than a largest diameter of the shafts, . . . ,of the set of the medical devices, . . . ,described in connection with. As such, the EM medical device instrument tracking apparatuscan receive any of the medical devices, . . . ,. The illustrated embodiment shows the EM medical device instrument tracking apparatuswith the medical devices.

15 FIG. 1 FIG. 1 FIG. 4 4 FIGS.A andB 4 FIG.A 4 FIG.B 15 FIG. 4 FIG.B 102 204 108 108 108 108 108 120 108 120 104 102 104 108 120 schematically illustrates another example in which the EM medical device instrument tracking apparatus. As discussed herein, the closer the EM sensor() is to the instrument(), the more accurate is the tracking of the instrument. As shown in, different instrumentsmay have different sizes, such as a length along the axis of the instruments. For example, in, the instrument(a blade, a needle, scissors, etc.) can be considered at the end of the shaft, whereas in, the instrument(an ablation catheter, etc.) may extend a few centimeters along the length of the shaft. As such, different EM medical device instrument tracking apparatusesmay have different lengths.depicts the EM medical device instrument tracking apparatusconfigured for medical devicewith the instrumentthat extends a few centimeters along the length of the shaftsuch as the ablation instrument discussed in connection with.

16 FIG. illustrates a non-limiting example of a flow chart for a method employing the apparatus for placement of the tracking sensor near the instrument with the medical device. It is to be appreciated that the ordering of the acts in the method is not limiting. As such, other orderings are contemplated herein. In addition, one or more acts may be omitted, and/or one or more additional acts may be included.

1602 106 104 104 1604 102 106 102 106 1606 106 102 1608 102 106 1610 102 104 At, the medical devicefor a procedure is selected. For example, the medical deviceis selected based on the type of procedure, etc. In one instance, this includes selecting a particular gauge associated with the medical device. At, the EM medical device instrument tracking apparatuscorresponding to the selected medical deviceis selected. In one instance, this includes selecting the EM medical device instrument tracking apparatusfor the gauge of the medical device. At, the selected medical deviceis installed in the EM medical device instrument tracking apparatus, as described herein and/or otherwise. At, the EM medical device instrument tracking apparatusis fastened to the selected medical device, as described herein and/or otherwise. At, the electrical pathway of the EM medical device instrument tracking apparatusis connected to the tracking system.

106 102 102 106 106 102 102 102 102 102 102 102 102 The medical device/EM medical device instrument tracking apparatuscombination is then employed in an ultrasound image guided procedure, as described herein and/or otherwise. For instance, the EM medical device instrument tracking apparatusis used to track the advancement of the medical deviceto tissue of interest, e.g., through presenting an ultrasound image with graphical indicia representing the instrument superimposed thereover at a location determined by the signals from the EM sensor. After the procedure, the medical deviceis uninstalled from the EM medical device instrument tracking apparatus. Where the EM medical device instrument tracking apparatusis disposable, the EM medical device instrument tracking apparatusis disposed. Where the EM medical device instrument tracking apparatusis reusable, the EM medical device instrument tracking apparatusis sanitized and/or disinfected. The EM medical device instrument tracking apparatuscan then be re-used for another ultrasound image guided procedure. Where the EM medical device instrument tracking apparatusis disposable, the EM medical device instrument tracking apparatusis disposed.

As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural of said elements or steps, unless such exclusion is explicitly stated. Furthermore, references to “one embodiment” of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, embodiments “comprising,” “including,” or “having” an element or a plurality of elements having a particular property may include such additional elements not having that property. The terms “including” and “in which” are used as the plain-language equivalents of the respective terms “comprising” and “wherein.” Moreover, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements or a particular positional order on their objects.

The various embodiments and/or components, for example, the modules, or components and controllers therein, also may be implemented as part of one or more computers or processors. The computer or processor may include a computing device, an input device, a display unit and an interface, for example, for accessing the Internet. The computer or processor may include a microprocessor. The microprocessor may be connected to a communication bus. The computer or processor may also include a memory. The memory may include Random Access Memory (RAM) and Read Only Memory (ROM). The computer or processor further may include a storage device, which may be a hard disk drive or a removable storage drive such as a floppy disk drive, optical disk drive, and the like. The storage device may also be other similar means for loading computer programs or other instructions into the computer or processor.

As used herein, the term “computer” or “module” may include any processor-based or microprocessor-based system including systems using microcontrollers, reduced instruction set computers (RISC), application specific integrated circuits (ASICs), logic circuits, and any other circuit or processor capable of executing the functions described herein. The above examples are exemplary only and are thus not intended to limit in any way the definition and/or meaning of the term “computer.” The computer or processor executes a set of instructions that are stored in one or more storage elements, in order to process input data. The storage elements may also store data or other information as desired or needed. The storage element may be in the form of an information source or a physical memory element within a processing machine.

The set of instructions may include various commands that instruct the computer or processor as a processing machine to perform specific operations such as the methods and processes of the various embodiments of the invention. The set of instructions may be in the form of a software program. The software may be in various forms such as system software or application software. Further, the software may be in the form of a collection of separate programs or modules, a program module within a larger program or a portion of a program module. The software also may include modular programming in the form of object-oriented programming. The processing of input data by the processing machine may be in response to operator commands, or in response to results of previous processing, or in response to a request made by another processing machine.

As used herein, the terms “software” and “firmware” are interchangeable, and include any computer program stored in memory for execution by a computer, including RAM memory, ROM memory, EPROM memory, EEPROM memory, and non-volatile RAM (NVRAM) memory. The above memory types are exemplary only, and are thus not limiting as to the types of memory usable for storage of a computer program.

It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the various embodiments of the invention without departing from their scope. While the dimensions and types of materials described herein are intended to define the parameters of the various embodiments of the invention, the embodiments are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description.

This written description uses examples to disclose the various embodiments of the invention, including the best mode, and also to enable any person skilled in the art to practice the various embodiments of the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the various embodiments of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if the examples have structural elements that do not differ from the literal language of the claims, or if the examples include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Embodiments of the present disclosure shown in the drawings and described above are example embodiments only and are not intended to limit the scope of the appended claims, including any equivalents as included within the scope of the claims. Various modifications are possible and will be readily apparent to the skilled person in the art. It is intended that any combination of non-mutually exclusive features described herein are within the scope of the present disclosure. That is, features of the described embodiments can be combined with any appropriate aspect described above and optional features of any one aspect can be combined with any other appropriate aspect. Similarly, features set forth in dependent claims can be combined with non-mutually exclusive features of other dependent claims, particularly where the dependent claims depend on the same independent claim. Single claim dependencies may have been used in practice as some jurisdictions require them, but this should not be taken to mean that the features in the dependent claims are mutually exclusive.